(Senior) Regulatory and Start Up Specialist

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are hiring a (Senior) Regulatory and Start Up Specialist with ideally contracts and budget experience to join our team in France. This position can be offered fully home based.

Essential functions of the job include but are not limited to:

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

• Maintenance of project plans and project trackers.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including site contracts and budget negotiation requirements.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.

 Experience /Qualifications

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory/ SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Experience drafting, reviewing and negotiating agreements related to clinical research.
• Experience developing and negotiating the budget.  

Other Required:

• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in French and English.

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of
• Strong organizational
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the
• Must demonstrate excellent computer
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade.
• Occasional travel may be required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.